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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K042653
Device Name PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP
Applicant
Pack & Proper Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
Pack & Proper Co., Ltd.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact JEN KE-MIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/28/2004
Decision Date 11/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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